Reported Nov 18, 2020 · Terminated
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only
- Manufactured byActavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314
- Distributed byActavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22
- Lot codes and dates
Lot #s: 1342498AExp. 12/20201342499AExp. 01/20211354638AExp. 03/20211354639A1358274A1358448A1364618A1369884AExp. 05/20211366195A1369885A1373570AExp. 06/20211373571AExp. 07/20211388571AExp. 01/20221395725A1396585A1397550A1399389AExp. 04/20221403885A1403886AExp. 06/2022
- Amount recalled
- 133,829 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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